CORE--CLINICAL

核心--临床

• 批准号: 6588844
• 负责人: GUILLERMO RUIZ-PALACIOS
• 金额: $ 17.24万
• 依托单位: EASTERN VIRGINIA MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-04-01 至 2003-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6588844
• 关键词: Mexico; biomedical facility; breast feeding; clinical research; clinical trials; epidemiology; field study; gastroenteritis; human milk; human subject; infant human (0-1 year); nutrition related tag; patient /disease registry

Description: The backbone of this program project is the Clinical Site Core which unites the overall aims of the proposal: 1) to isolate, characterize, and synthesize the bioactive substances in human milk (including glycoconjugates, antibodies, and anti-inflammatory factors) that protect the infant from enteropathogens; 2) to evaluate, through molecular-epidemiologic research, the protection of breast-fed infants from enteropathogens; 3) to determine, through randomized trials, the efficacy of specific bioactive substances identified in human milk to protect the infant from enteric infection and disease; and 4) to determine the effect of human milk on modulation of the immune response to enteric pathogens and vaccines. In the previous funding period of the previous application, the Clinical Site Core supported all projects. This included the sharing of demographic data and specimens, conducting field studies in Mexico (San Pedro Martir, Tlalpan) and Norfolk, specimen collection from Mexican and U.S. mothers, as well as biochemical, and biostatistical support. Field studies originating in 1987 in Mexico have enrolled in excess of 600 infants and 400 mothers. Additional studies (funded outside this project) enrolled over 600 infants in Norfolk. The Core maintained a database of all biological samples which was shared by all investigators. There have been over 2,800 milk, 1,600 blood, and 32,000 fecal samples collected, much of which has been depleted for analyses in the specific projects during 1993-8. Some of the remaining fecal samples can be used for the proposed projects, but there remain too few blood and milk samples and/or additional samples are needed to address newer aims in the current proposal.

描述：该计划项目的支柱是临床站点核心 它统一了该提案的总体目标：1）隔离、描述、 并合成母乳中的生物活性物质（包括 糖缀合物、抗体和抗炎因子），保护 婴儿免受肠道病原体感染； 2）通过分子流行病学评估 研究，保护母乳喂养的婴儿免受肠道病原体的侵害； 3）到 通过随机试验确定特定生物活性物质的功效 在母乳中发现的可保护婴儿免受肠道感染的物质 感染和疾病； 4) 确定母乳对 调节对肠道病原体和疫苗的免疫反应。 在先前申请的先前资助期内，临床中心 核心支持所有项目。这包括共享人口数据 和标本，在墨西哥进行实地研究（圣佩德罗马蒂尔，特拉尔潘） 和诺福克，墨西哥和美国母亲的标本收集，以及 生化和生物统计支持。实地研究始于 1987 年 墨西哥已招募了超过 600 名婴儿和 400 名母亲。额外的 研究（在本项目之外资助）在诺福克招募了 600 多名婴儿。 核心维护着所有生物样本的数据库，该数据库由 所有调查员。已有超过 2,800 份牛奶、1,600 份血液和 32,000 份 收集的粪便样本，其中大部分已耗尽用于分析 1993年8月期间的具体项目。一些剩余的粪便样本可以 用于拟议的项目，但血液和牛奶仍然太少 需要样本和/或额外样本来解决新的目标 当前的提案。